Hospital-to-home support for children and youth with special health care needs

Hospital-to-Home Care Coordination for Children and Youth With Special Health Care Needs

This trial tests whether a single post-discharge phone call or weekly phone calls for a month better help hospitalized children and youth with special health care needs and their parents reduce acute care use and increase parent confidence.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 480 (estimated)
• Ages: N/A to 18 Years
• Sex: All
• Sponsor: Duke University (Academic / other)
• Locations: 2 sites (Chapel Hill, North Carolina and 1 other locations)
• Trial ID: NCT06428175 on ClinicalTrials.gov

What this trial studies

This randomized study assigns hospitalized children and youth with special health care needs and their adult caregivers to either a focused-dose transitional care intervention (one post-discharge phone call) or an extended-dose intervention (weekly phone calls for one month). Primary outcomes are health service use (e.g., emergency visits, readmissions) and parent-reported confidence in managing the child's care at home. The trial includes subgroup analyses for clinically complex and racially/ethnically vulnerable children and uses EHR data plus caregiver reports for outcome measurement. A parallel mixed-methods implementation evaluation will examine context, processes, and mechanisms affecting delivery and impact.

Who should consider this trial

Good fit: Ideal candidates are children under 18 who have seen two or more outpatient specialty areas in the past year, are hospitalized on a general pediatrics service at a participating site, and have an adult caregiver available to participate.

Not a fit: Children discharged to non-home settings, those already receiving intensive transitional care, or children under ongoing social services investigation or who are wards of the state are excluded and unlikely to benefit from these interventions.

Why it matters

Potential benefit: If successful, the interventions could lower emergency visits and readmissions and increase caregiver confidence in managing the child's care at home.

How similar studies have performed: Transitional care programs in adults have reduced readmissions and small pediatric studies suggest benefit, but randomized, dose-comparison evidence in children and youth with special health care needs is limited.

Eligibility criteria

Inclusion Criteria:

* For this study, eligible children/youth with special health care needs (CYSHCN) and adult parent/caregiver dyads will be those who meet the following inclusion criteria:

  1. Child is a CYSHCN, defined as having seen two or more distinct specialty areas for outpatient visits during the 12 months prior to index hospitalization admission date
  2. Age of hospitalized child is under 18 years old
  3. Child hospitalized on a general pediatrics inpatient service line at participating site
  4. Adult parent/caregiver for the child is 18 years or older

Exclusion Criteria:

* Child exclusion criteria:

  1. Child will be discharged to any location besides home (e.g., long-term care or residential facility, skilled nursing facility, inpatient acute rehabilitation, psychiatric facility)
  2. Child is a ward of the state or has an ongoing social services investigation
  3. Child is already receiving transitional care, intensive longitudinal care coordination (e.g., organ/disease-specific clinical program, clinical division within the same institution as the hospital \[e.g., Children's Complex Care Program at UNC; Complex Care Service at Duke\]), and/or longitudinal population health care coordination as part of a bundled alternative payment care model.
* Parent/caregiver exclusion criteria include:

  1. Age less than 18 years old
  2. Diminished capacity to provide consent/participate
  3. Primary language for parent/caregiver is any language besides English or Spanish

Where this trial is running

Chapel Hill, North Carolina and 1 other locations

• UNC Hospitals — Chapel Hill, North Carolina, United States (Recruiting)
• Duhs — Durham, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: David Ming, MD — Duke University
• Study coordinator: Jennifer Thomas, MPH

Conditions Health Care; Pediatrics; Transitional Care; Comparative Effectiveness; Family Engagement; Special Needs; Hospital to Home Care; Children and Youth with Special Health Care Needs